KDMF (Korea Drug Master File) Approved Products & Companies

  • Product:

    Cefuroxim axetyl

  • Initial Registration:

    2010-08-31

  • Registration Number:

    20100831-22-A-236-08

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Sechang International Co., Ltd.

  • Last Modified:

    2025-03-04

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Nectar Lifesciences Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2023

  • Manufacturing Facility:

    Unit-II, Village Saidpura, Tehsil DeraBassi, District Sahibzada Ajit Singh Nagar – 140507, Punjab, India.

  • Product:

    Glyclazide

  • Initial Registration:

    2012-03-16

  • Registration Number:

    20050831-1-C-5-03(3)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Seil Pharmaceutical Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Shandong Keyuan Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2015

  • Manufacturing Facility:

    Keyuan Street, Shandong Shanghe Economic Development Zone, Jinan City, Shandong, China

  • Product:

    Clarithromycin

  • Initial Registration:

    2016-08-10

  • Registration Number:

    20130123-62-A-268-19(8)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Seintech Pharma Co., Ltd.

  • Last Modified:

    2022-11-17

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Zhejiang Guobang Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2024

  • Manufacturing Facility:

    No. 6, Weiwu Road, Hangzhou Gulf Shangyu Economic and Technological Development Zone, Zhejiang, China

  • Product:

    Choline alfoscerate

  • Initial Registration:

    2012-12-27

  • Registration Number:

    20120316-168-I-18-01(2)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Seohung Co., Ltd.

  • Last Modified:

  • Country:

    Italy

  • Status:

    Active

  • Manufacturer:

    EUTICALS SPA

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2015

  • Manufacturing Facility:

    Viale Milano 86-26900 Lodi, Italy

  • Product:

    sodium hyaluronate

  • Initial Registration:

    2017-09-07

  • Registration Number:

    20151016-96-E-123-38(5)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Seongji Ivy Farm

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Bloomage Freda Biopharm Co., Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    No.678 Tianchen St., High-Tech Development Zone, Jinan City, Shangdong Province, China

  • Product:

    Cefpodoxime proxetil

  • Initial Registration:

    2020-06-18

  • Registration Number:

    20200618-25-A-359-12

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Seongun Pharmacopia Co., Ltd.

  • Last Modified:

    2022-06-10

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Qilu Antibiotics Pharmaceutical Co., Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    No.849 Dongjia Town, Licheng District, Jinan, Shandong Province, China

  • Product:

    Enalapril maleate

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-12-B-51-08

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Seongwoo Chemical Co., Ltd.

  • Last Modified:

    2025-12-31

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Zhejiang Huahai Pharmaceutical co., ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2018

  • Manufacturing Facility:

    Lizhuang, Xunqiao, Linhai, 317024, Zhejiang, China

  • Product:

    Cefuroxim axetyl

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-22-A-32-05

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Seongyi Bio Co., Ltd.

  • Last Modified:

    2021-07-26

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Orchid Pharma Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2015

  • Manufacturing Facility:

    Plot Nos. 121-128, 128A-133, 138-151, 159-164, SIDCO Industrial Estate, Alathur-603 110, Kancheepuram District, India

  • Product:

    Metformin hydrochloride

  • Initial Registration:

    2012-10-12

  • Registration Number:

    20050915-37-C-196-11(1)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Seongyi Pharmaceutical Co., Ltd.

  • Last Modified:

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Aurobindo Pharma ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Survey No. 388 & 389 Borapatla village, Hathnoora mandal Medak District, Andhra Pradesh, India

  • Product:

    Fluoxetine hydrochloride

  • Initial Registration:

    2012-03-09

  • Registration Number:

    20050831-51-C-175-04(3)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Seoul Pharmaceutical Co., Ltd.

  • Last Modified:

    2023-06-19

  • Country:

    Spain

  • Status:

    Withdrawal

  • Manufacturer:

    Union quimico farmaceutica, SA

  • Withdrawal Date:

    2023-06-19

  • Final Annual Reporting Year:

    2022

  • Manufacturing Facility:

    Poligon Industrial El PlaAv. Puigcerda No.9 c-17 km 17.408185 Llica de Vall, Barcelona Spain

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